TinnitusNCT01176734
The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve Stimulation
A study testing tVNS-Device in people with Tinnitus, run by cerbomed GmbH at 1 site in Germany.
Trial summary
The t-VNS STv3 device is a non-invasive, transcutaneous neurostimulator for influencing the afferent branches of the nervus vagus around the human ear. The clinical trial is designed as a a pilot study addressing the treatment of tinnitus with transcutaneous vagus nerve stimulation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- tVNS-Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic tinnitus defined as a tinnitus over more than six months
- ≥31 points in the tinnitus questionnaire according to Goebel and Hiller
- Written informed consent
- Both gender, aged from 18 -75 years
- If the subject takes psychoactive medication (e.g antidepressants, anticonvulsives) therapy must be stable for at least 10 days. If a treatment with neuroleptics is necessary, only olanzapine and quetiapine should be used. The therapy should be constantly though a necessary change in medication is no reason for exclusion of the subject.
Who cannot join
- Objective tinnitus
- Participating in other tinnitus treatments within 3 months before study start
- Missing informed consent
- Pregnancy
- Bronchial asthma in medical history
- Clinically relevant internistic, neurological or psychiatric diseases
Show all 13Show fewer
- Abuse of drugs or alcohol until 12 weeks before enrollment in the study
- Indications of structural impairment of the basal ganglia or the brain stem
- Active implants (e.g. cochlea implants, VNS, pacemaker)
- Constant all-day use of hearing instruments or noisers on the left the part-time use in special situations (e.g. watching TV is no exclusion criteria
- All dermatologic and infectious diseases which affect the area around the pinna and the ear canal
- Severe malformation of the pinna
- Other circumstances that in the opinion of the investigator might be an obstacle for enrolling the subject
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Psychiatrie und Psychotherapie Bezirksklinikum Regensburg Universitätsstr. 84 93053 Regensburg E-mail: Berthold.Langguth@medbo.de Tel.: 0941 941 2099 Fax.: 0941 941 2025 Dr. med Michael Landgrebe, Klinik für Psychiatrie und Psychotherapie Bezir
Regensburg, Bavaria, 93053
About this study
Official title: The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve stimulation-a Controlled Randomized Pilot Study Assessing Safety, Compatibility and Clinical Performance
The t-VNS STv3 device is a non-invasive, transcutaneous neurostimulator for influencing the afferent branches of the nervus vagus around the human ear. The clinical trial is designed as a a pilot study addressing the treatment of tinnitus with transcutaneous vagus nerve stimulation.
- Conditions
- Tinnitus
- Being tested
- tVNS-Device
- Keywords
- Pulsatile Tinnitus, Ringing-Buzzing-Tinnitus, Spontaneous Oto-Acoustic Emission Tinnitus, Tensor Palatini Induced Tinnitus, Tensor Tympani Induced Tinnitus, Tinnitus of Vascular Origin, Tinnitus, Clicking, Tinnitus, Leudet, Tinnitus, Leudet's, Tinnitus, Noise Induced, Tinnitus, Objective, Tinnitus, Spontaneous Oto-Acoustic Emission, Tinnitus, Subjective, Tinnitus, Tensor Palatini Induced, Tinnitus, Tensor Tympani Induced, Vascular Origin Tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tVNS-DeviceDevice
Active treatment with the t-VNS device.
| Study group | Role | What they receive |
|---|---|---|
| active t-VNS | Experimental | active t-VNS Receives: Device: tVNS-Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, feasibility and effectiveness of t-VNS® stimulation
Determination of safety, feasibility and effectiveness of t-VNS measured by tinnitus score according to Goebel and Hiller between baseline and week 24
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- cerbomed GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Berthold Langguth, MD, Principal investigator, University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176734
- Sponsor's protocol ID
- cMPsTIN01
- Status last verified
- Apr 2013
- First submitted
- 5 Aug 2010
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kreuzer PM, Landgrebe M, Resch M, Husser O, Schecklmann M, Geisreiter F, Poeppl TB, Prasser SJ, Hajak G, Rupprecht R, Langguth B. Feasibility, safety and efficacy of transcutaneous vagus nerve stimulation in chronic tinnitus: an open pilot study. Brain Stimul. 2014 Sep-Oct;7(5):740-7. doi: 10.1016/j.brs.2014.05.003. Epub 2014 Jun 4.
PubMed 24996510
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve stimulation-a Controlled Randomized Pilot Study Assessing Safety, Compatibility and Clinical Performance
- ClinicalTrials.gov ID
- NCT01176734
- Acronym / sponsor ID
- cMPsTIN01
- Conditions
- Tinnitus
- Keywords
- Pulsatile Tinnitus, Ringing-Buzzing-Tinnitus, Spontaneous Oto-Acoustic Emission Tinnitus, Tensor Palatini Induced Tinnitus, Tensor Tympani Induced Tinnitus, Tinnitus of Vascular Origin, Tinnitus, Clicking, Tinnitus, Leudet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- cerbomed GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 6 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The t-VNS STv3 device is a non-invasive, transcutaneous neurostimulator for influencing the afferent branches of the nervus vagus around the human ear. The clinical trial is designed as a a pilot study addressing the treatment of tinnitus with transcutaneous vagus nerve stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| active t-VNS | Experimental | Device: tVNS-Deviceactive t-VNS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic tinnitus defined as a tinnitus over more than six months
- ≥31 points in the tinnitus questionnaire according to Goebel and Hiller
- Written informed consent
- Both gender, aged from 18 -75 years
- If the subject takes psychoactive medication (e.g antidepressants, anticonvulsives) therapy must be stable for at least 10 days. If a treatment with neuroleptics is necessary, only olanzapine and quetiapine should be used. The therapy should be constantly though a necessary change in medication is no reason for exclusion of the subject.
Key exclusion criteria (13 listed)
- Objective tinnitus
- Participating in other tinnitus treatments within 3 months before study start
- Missing informed consent
- Pregnancy
- Bronchial asthma in medical history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tVNS-DeviceActive treatment with the t-VNS device. | Device | active t-VNS |
Primary outcome
Safety, feasibility and effectiveness of t-VNS® stimulation
Time frame: 24 weeks
Determination of safety, feasibility and effectiveness of t-VNS measured by tinnitus score according to Goebel and Hiller between baseline and week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
- Derived from this study: PubMed 24996510Kreuzer PM, Landgrebe M, Resch M, Husser O, Schecklmann M, Geisreiter F, Poeppl TB, Prasser SJ, Hajak G, Rupprecht R, Langguth B. Feasibility, safety and efficacy of transcutaneous vagus nerve stimulation in chronic tinnitus: an open pilot study. Brain Stimul. 2014 Sep-Oct;7(5):740-7. doi: 10.1016/j.brs.2014.05.003. Epub 2014 Jun 4.
Related trials for Tinnitus
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingPhase 2
A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berthold Langguth, MD principal investigator
University of Regensburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tVNS-Device in people with Tinnitus, run by cerbomed GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, feasibility and effectiveness of t-VNS® stimulation (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01176734, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2013.